Patterns of Failure [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Evaluate locoregional recurrences to see if they arise in regions that were spared vs. treated, and assess long-term control after salvage therapy.

Time to Relapse [ Time Frame: first day of therapy to the first sign of progressive disease ] [ Designated as safety issue: No ]

Imaging for recurrence via CT scan will occur at 8 weeks (+/-5 days) post-RT, and will be repeated at 6, 9, 12, and 24 months from start of treatment.

Morbidity of Treatment [ Time Frame: From screening until 30 days after treatment ] [ Designated as safety issue: Yes ]

Toxicity will be assessed according to the NCI CTCAE v4.

Original Secondary Outcome Measures ICMJE

Same as current

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Selective IMRT for Locally Advanced Head and Neck Carcinoma With Concurrent Panitumumab

Official Title ICMJE

Selective IMRT for Locally Advanced Head and Neck Carcinoma With Concurrent Panitumumab

Brief Summary

This is a non-randomized phase II study of targeted radiotherapy (RT) administered concurrently with panitumumab in patients with locally advanced squamous carcinoma of the head and neck.

Detailed Description

This is a non-randomized phase II trial of targeted radiotherapy (RT) administered concurrently with panitumumab in patients with locally advanced squamous cell carcinoma of the head and neck. This protocol addresses patients with medical comorbidities that make them poor candidates for concurrent chemotherapy. Radiotherapy treatment will be directed at disease visible on diagnostic imaging modalities and the ipsilateral hemi-neck, sparing elective regions in the contralateral N0 hemi-neck with less than 20% chance of microscopic involvement. We explore the following hypothesis: Can acceptable locoregional disease control be obtained with less treatment-related morbidity by focusing RT on regions of gross disease, sparing regions with a low risk of harboring subclinical disease from elective RT?

Patients are eligible if they have concurrent medical conditions that render them poor candidates for chemotherapy. Patients are considered to be in this group if any of the following criteria is met: Serum creatinine >1.5 mg/dl (or estimated creatinine clearance <50mL/min); Insulin dependent diabetes; SGOT, SGPT, or alkaline phosphatase >2.5 x upper limit of normal; History of significant CAD (myocardial infarction [MI], coronary artery bypass graft [CABG], coronary stents, symptomatic angina); Congestive heart failure [CHF] (LVEF <40% by echocardiogram or MUGA); nephropathy; Prior history of malignancy treated with chemotherapy; Severe chronic obstructive pulmonary disease [COPD], defined as FEV1 <1L; In the opinion of the treating physician, patient would not tolerate the administration of concurrent chemotherapy and radiation

The patient may have had a prior malignancy but must be disease-free for three years prior to study entry. A history of superficial non-melanoma skin cancer or in situ carcinoma of the cervix less than three years will be allowed.

The patient must agree to use effective contraception if childbearing potential exists and continue contraception for at least 6 months following completion of the study.

Evaluation by dental services prior to initiation of radiation therapy.

Patient must be informed of the investigational nature of the study and sign an informed consent form.

Exclusion Criteria:

The patient has received radiation therapy previously to the head and neck. NOTE: Previous radiotherapy for skin cancers of the head and neck are permitted if the fields do not overlap significantly.

All gross disease has been surgically resected. NOTE: Patients who have had an excisional neck biopsy will not be eligible.